Clinical trial · Interventional
Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy
A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Treatment for head and neck cancer often involves a combination of chemotherapy and radiation. One of the unfortunate consequences of standard care for head and neck cancer is the development of painful mouth sores, known as oral mucositis. This study will evaluate the use of cobiprostone spray to prevent oral mucositis, when given for the duration of radiation and chemotherapy (RT/CT) standard care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cobiprostone | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Standard Care - Chemotherapy | Drug | — | UNRESOLVED |
| Standard Care - Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cobiprostone 30 mcg four times daily
- description
- Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
- interventionNames
- Drug: Cobiprostone
- Drug: Standard Care - Chemotherapy
- Radiation: Standard Care - Radiation
- type
- PLACEBO_COMPARATOR
- label
- Placebo 0 mcg four times daily
- description
- Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
- interventionNames
- Drug: Placebo
- Drug: Standard Care - Chemotherapy
- Radiation: Standard Care - Radiation
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recently-diagnosed (within the last 6 months), histologically-documented, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality. * Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose administered via continuous course of external beam irradiation to the oral cavity and/or oropharynx via intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), combined with conventional or weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen. Exclusion Criteria: * Subject has received prior radiation to the head and neck region (+/- chemotherapy). * Subject has had any other prior invasive malignancy, unless disease-free for a minimum of 3 years. * Subject has metastatic disease (M1) Stage IV-C. * Subject has a presence of mucosal ulceration or oral mucositis at screening or develops this prior to randomization, and/or has unhealed wounds remaining from surgical resection and/or excisional biopsy procedure. * Subject is using a pre-existing feeding tube for nutritional support at study entry.
References
Publications (0)
Data not yet available